Neuropsychological Assessment Of The Oldest-Old Population.(NEUROPSIC-GR)

NCT05481749 | Recruiting

• 1 other identifier: CSAPG-23v2
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 6

Brief Summary

Neuropsychological tests currently considered to evaluate the cognitive performance of the oldest-old population (more than 80 years) are not adapted to this group population. This trial aims to determine the normal limits for this group population of a set of 18 neuropsychological test. Results may improve the diagnostic cognitive evaluation of this population.

Conditions

Dementia; Cognition Disorders in Old Age

Keywords

Geriatric Assessment; Aged, 80 and over; Dementia; Cognition Disorders in Old Age

Outcome Measures

Primary Outcomes (1)

• Cognitive Performance

  Cognitive performance will be evaluated by 18 neuropsychological test (quantitative scores) which cover all main cognitive domains (memory and learning, language, perceptual-motor abilities, executive functions and attention).

  This outcome will be evaluated at Memory Clinic Unit, following the enrollment visit. The evaluation of this outcome will last approximately 60 minutes.

Study Arms (1)

Neuropsico-Ger

People aged 80 or more years, non-institutionalized, and without pathologies potentially affecting cognitive status.

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

80 or more years old non-institutionalized residents at Comarca del Garraf, a spanish region located at Barcelona Province, with a total of 112 195 people aged 80 years or more registered at public health system.

You may qualify if:

• or more years old
• Residence at Comarca del Garraf
• Able to be transfered to study center
• Sufficient reading and writing capacity to carry out the neuropsychological tests, at the evaluator's discretion.

You may not qualify if:

• Patient at end-of-life situation or with a very short life expectancy (days-weeks).
• Hospital admission in the previous 3 months.
• History of relevant mental illness: major depression, psychosis, bipolar disorder, obsessive-compulsive disorder.
• Disease of the central nervous system with possible cognitive impairment: Parkinson's disease, multiple sclerosis, brain tumor, stroke with cognitive impairment, epilepsy, severe traumatic brain injury.
• History of alcoholism or substance abuse.
• Severe sensory deficit that prevents performing neuropsychological tests, at the discretion of the evaluator.
• Positive Shortened Spanish Informant Questionnaire for Cognitive Decline in the Elderly questionnaire (SS-IQCODE) or Lobo's Cognitive Mini-examination Test (spanish adaptation of Minimental of Folstein test) with a score \< 23 (20 in people with low schooling or illiteracy).
• Dementia criteria according to the Diagnostic and Statistical Manual of Mental Disorders IV.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead
• Centro de Salud Vilanova i la Geltrú 2 Jaume I, Barcelona, Spain: collaborator
• Centro de Salud Vilanova i la Geltrú 3 Baix A Mar, Barcelona, Spain: collaborator
• Centro de Salud Les Roquetes-Sant Pere de Ribes, Barcelona, Spain: collaborator
• Gerència Territorial Metropolitana Sud, Alt Penedès i Garraf, Barcelona, Spain: collaborator
• Centro de Salud Sant Pere de Ribes, Barcelona, Spain: collaborator
• Centro de Salud Vilanova i la Geltrú 1 Sant Joan, Barcelona, Spain: collaborator
• Centro de Salud Sitges, Barcelona, Spain: collaborator

Study Sites (6)

Centro de Salud Les Roquetes-Sant Pere de Ribes

Sant Pere de Ribes, Barcelona, Spain

RECRUITING

Centros de Salud Sitges

Sitges, Barcelona, Spain

RECRUITING

Centro de Salud Vilanova i la Geltrú 1

Vilanova i la Geltrú, Barcelona, Spain

RECRUITING

Centro de Salud Vilanova i la Geltrú 2 Jaume I

Vilanova i la Geltrú, Barcelona, Spain

RECRUITING

Centro de Salud Vilanova i la Geltrú 3 Baix A Mar

Vilanova i la Geltrú, Barcelona, Spain

RECRUITING

Centro de Salud Sant Pere de Ribes

Sant Pere de Ribes, Barcelone, 08810, Spain

RECRUITING

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MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• César Gálvez-Barrón, Ph.D.

  Consorci Sanitari de l'Alt Penedès i Garraf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

César Gálvez-Barrón, Ph.D.

CONTACT

0034 626419884; cgalvez@csapg.cat

Noemi Casaponsa

CONTACT

+34 938960025; recerca@csapg.cat

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: February 14, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of main results of the study.
• Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations

ES (6)